Brilliance in photodynamic technology TM
First quarter 2007
April 25th, 2007
Kjetil Hestdal, President & CEO and Christian Fekete, CFO
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Hexvix commercialisation gaining momentumHexvix revenue increased to MNOK 2.1 (0.1) in rest of EuropeHexvix revenue increased to MNOK 1.6 (0.3) in the Nordic region
Increased sales of MetvixMetvix revenue increased 33% outside the Nordic region to MNOK 9.9Metvix revenue MNOK 5.4 (5.4) in the Nordic regionMetvix recommended as first line treatment for AK in new IPDT guildelines
Important milestones reached in R&DCompleted two phase III Metvix/Aktilite studiesStarted phase II study in acne in the USPresented preliminary phase I/II data in detection of colon cancerFiled 2 patent applications for combination of siRNA/PNA and PCI technology
Brilliance in photodynamic technology TM
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Financial statements - Profit & loss first quarter 2007 (group)
2007 2006 20061.1-31.03 1.1-31.03 1.1-31.12
Sales revenues 19 006 13 285 61 667Signing fee and milestone revenues 3 908 60 538 148 653Total revenues 22 914 73 823 210 320Cost of products sold -6 588 -3 564 -22 251Gross profit 16 326 70 259 188 070Other income 1 694 1 388 5 690Indirect manufacturing expenses -3 696 -1 669 -5 880Research and development expenses -22 644 -15 668 -56 058Marketing and sales expenses -8 766 -5 496 -23 068General and administrative expenses -3 324 -6 135 -30 412Operating profit/loss(-) -20 410 42 679 78 342Financial income 3 254 1 039 11 867Financial expenses -627 -749 -5 478Net financial profit/loss(-) 2 626 290 6 389Profit/loss(-) before tax -17 784 42 970 84 730Tax expenses 0 0 0Net profit/loss(-) -17 784 42 970 84 730Incl. m inority interests in the amount of -151 -72 -352 Net income/loss(-) per share, basic -0.81 2.25 3.98 Net income/loss(-) per share, diluted -0.80 2.24 3.97
Sales revenues increasing by 43% to MNOK 19.0New classification of expenses from 1.1.2007
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Financial statements - Segment information (group)
Allocation of operating expenses to the geographical segments have been changed for 2006 in order to present a more accurate allocation.
Sales revenues for Metvix ROW increasing by 33% to MNOK 9.9Sales revenues for Hexvix increasing to MNOK 3.7R&D separate segment from 1.1.2007
Income statement - geographical distribution
(Amounts in NOK 1000) 1Q07
Nordic ROW R&D* Total Nordic ROW R&D* TotalSales revenue 7 024 11 982 0 19 006 5 710 7 575 0 13 285Milestone revenue 0 3 908 0 3 908 0 60 538 0 60 538Total revenues 7 024 15 891 0 22 914 5 710 68 113 0 73 823Cost of goods sold 730 5 858 0 6 588 621 2 943 0 3 564Gross profit 6 294 10 033 0 16 326 5 088 65 171 0 70 259Gross profit % 90 % 63 % 71 % 89 % 96 % 95 %Operating expenses 8 680 4 861 23 195 36 736 5 899 5 570 16 110 27 580Operating profit -2 386 5 171 -23 195 -20 410 -811 59 600 -16 110 42 679Net finance 0 0 2 626 2 626 0 0 290 290Profit before tax -2 386 5 171 -20 569 -17 784 -811 59 600 -15 820 42 970* Including share of general and administrative expenses and net finance
Sales revenues - product split
(Amounts in NOK 1000)Nordic ROW Total Nordic ROW Total
Metvix/Aktilite 5 391 9 924 15 315 5 414 7 443 12 857Hexvix 1 632 2 058 3 690 296 132 429Total 7 024 11 982 19 006 5 710 7 575 13 285ROW=Rest Of the World
1Q06
1Q07 1Q06
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Financial statements - balance sheet 31.03.2007 (group)
31.03.2007 31.03.2006 31.12.2006Non-currrent assetsIntangible assets, software 766 0 780Machinery & equipm ent 2 166 2 844 2 178Total non-current assets 2 932 2 844 2 958
Currrent assetsInventory 10 249 11 044 9 784Receivables 24 517 21 981 27 595Cash & cash equivalents 316 823 296 771 335 085Total current assets 351 588 329 795 372 464
Total assets 354 520 332 639 375 423Equity and liabilitiesEquityPaid-in capital 260 901 259 442 259 619Other paid-in capital 7 698 5 278 6 821Retained earnings 42 712 19 526 60 495Shareholders' equity 311 310 284 246 326 935Minority interest 0 0 0Total equity 311 310 284 246 326 935LiabilitiesLong-term liabilitiesOther non-current liabilities 0 13 028 1 303Total long-term liabilities 0 13 028 1 303Current liabilities 43 210 35 365 47 185Total liabilities 43 210 48 393 48 488Total equity and liabilities 354 520 332 639 375 423
Cash & cash quivalents of MNOK 316.8 per 31.3.2007Total balance of MNOK 354.5 per 31.3.2007
Brilliance in photodynamic technology TM
®
- a breakthrough in bladder cancer diagnostics
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Excellent feedback from urologists at EAU, Berlin satellite symposium
European awareness increasing
Critical success factors:
Establish reimbursement - ongoing
Increase base of scopes ongoing
Train urologists - ongoing
Introduced in Germany, Austria, France, Spain, Portugal, UK, Baltics and Greece.
Established price of 400 per kit
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Audience Key messages
Urologists detects 30% more patients with bladder cancer
detects 67% more CIS lesions
improves management in 1 in 5 patients
Payors is cost-effective
is the only licensed product of its type
is proven to be effective with a well-controlled clinical programme
Patients andadvocates
improves the detection of bladder tumours and the identification of tumour margins, giving the doctor the possibility to carry out a more effective tumour removal.
Brilliance in photodynamic technology TM
® ®
- treatment of skin cancer without scarring
Approved for AK, BCC and Bowen s disease in EU
15 million patients diagnosed with AK annually in EU/US
Topical treatments gaining market share
Metvix offers patient benefits superior cosmetic outcome
Reimbursement is critical for Metvix growth
Metvix recommended as first-line treatment in IPDT guidelinesPDT is recommended as first-line treatment for AK, BD and sBCC in new International peer reviewed guidelines.
Treatment of NMSC (other than SCC) should be driven by:
efficacy, with due consideration tocosmetic outcome, and patient preference
Guidelines on the Use of PDT for Non-melanoma Skin Cancer - An International ConsensusBraathen et al, Journal of the American Academy of Dermatology 2007; 56: 125-143
AK patient before and after treatment with Metvix
Brilliance in photodynamic technology TM
- acne, cervix, colon and PCI Biotech
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Acne patient before treatment
Each year US doctors register ~ 3 million visits concerning acne, app. 70% of these have moderate to severe acne
Market for treatment of moderate to severe acne USD 1.3 billion per year
Existing treatments have significant side effects
Photocure has a patented technology in acne until 2018+
MAL PDT meets patient need for an effective treatment with limited side effects
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Started development of new lamp
Started phase IIb studyModerate to severe acneOver 200 patients in the USDose findingPlacebo controlledPrimary endpoint: reduction
of lesion countsReport scheduled for H108
Filed new method of use patents in acne and other dermatology indications
Illustration of Photocure s novel acne treatment
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Cervix first phase I/II study on schedule
Medical need for effective treatment of HPV infection and premalignant lesions
Large patient population over 3.5 million in US
Phase I/II study ongoing:dose findingNorway and Germanyapprox. 80 patients6 month follow-upreport scheduled for H2 2008
Started development of new lamp and new formulation
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High medical need for early detection of colon cancer. Inadequate methods available today:
22% miss rate on polyps62% miss rate on flat lesionsHuge endoscopy variation
13 million colonoscopies performed annually in EU/US
Phase I/II study ongoing:dose-finding2 centres in Germanyapprox. 30 patientsreport scheduled for 2007
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Investigator:Dr. Mayinger, Münich
Study design:12 patients with suspected colon cancer30-60 min HAL enema white + blue light inspection
Results:64 polyps Detection rate HAL+blue light 98% Detection rate white light 72%No side effects
Courtesy Mayinger, Munich
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The PCI technology can significantly enhance delivery of siRNATwo patent applications filed on a combination of PCI technology and oligonucleotide molecules (siRNA and PNA) therapy.
The goal is to deliver tailored cancer therapy.
New research agreement with Radium Hospital on development of PCI with siRNA/PNA.
Grant of NOK 8.5 mill. from Norwegian Research CouncilClinical studies and further development of Amphinex synthesis
Phase I clinical study project approved by ethical review committee
Animal toxicology studies document that Amphinex is well tolerated
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Continue investing in Metvix and Aktilite
Support Galderma in strengthening Metvix/Aktilite in dermatology
Seek Aktilite approval in the US
Commercialise Hexvix
Support GE Healthcare in introducing Hexvix in EU
Seek Hexvix approval in the US
Continue clinical development in acne, cervix, colon and PCI
Complete phase II study in acne in the US
Start first clinical study for PCI Biotech in Norway
Complete phase I/II studies in colon cancer and cervix cancer
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